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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05751538
Other study ID # AI-BE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 30, 2023

Study information

Verified date November 2022
Source Ruijin Hospital
Contact Jieming Qu
Phone 86-021-64370045
Email jmqu0906@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Chest computed tomography (CT) remains the imaging standard for demonstrating cystic fibrosis (CF) airway structural disease in vivo. However, visual scoring systems as an outcome measure are time consuming, require training and lack high reproducibility. Our objective was to validate a fully automated artificial intelligence (AI)-driven scoring system of CF lung disease severity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 730
Est. completion date December 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis) Exclusion Criteria: - Patients with CT data and medical records missing

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Ruijin Hospital, Medical School of Shanghai Jiaotong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlations of the artificial intelligence-driven scores with manual scores Correlations and comparisons of the artificial intelligence-driven scores with manual scores by thoracic radiologists on CT scans of bronchiectasis patients. From date of inclusion until the date of final quantification, assessed up to 12 months
Secondary Correlation of the artificial intelligence-driven scores with pulmonary function test Correlation of quantitative measurement with pulmonary function From date of inclusion until the date of final quantification, assessed up to 12 months
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